Improved Mood and Behavior During Treatment with a Mineral-Vitamin Supplement: An Open-Label Case Series of Children

Journal of Child and Adolescent Psychopharmacology
Volume 14, Number 1, 2004

Read the abstract on the National Library of Medicine website or read the editorial review of the actual Journal article below.

Summary of Case Report

A new clinical trial of EMPowerplus, this time involving nine children with mood and behavior problems, has proven again the veracity of Truehope’s claims that its product is helping people with bipolar and other psychiatric disorders. The study, supported in part by the Alberta Children’s Hospital Foundation and carried out by researchers from three Alberta universities, determined the nine participants showed improved behaviour during the trial and higher scores on standard psychiatric tests.

“In this open-label study of a broad-based nutrient treatment (EMPowerplus), the results demonstrated statistically significant improvements in mood and anxiety in the nine children who completed the trial,” the researchers noted in a recent issue of the Journal Of Child And Adolescent Psychopharmacology.

The trial was carried out by doctors Bonnie Kaplan of Paediatrics and Community Health Sciences, University of Calgary and the Behavioural Research Unit, Alberta Children’s Hospital (ACH); Jennifer Fisher, Department of Psychiatry, University of Calgary; Catherine Field of the Department of Agricultural, Food and Nutritional Science, University of Alberta in Edmonton; Bryan Kolb, Ph.D, of the Department of Psychology, University of Lethbridge; and Susan Crawford, MSc., a colleague of Kaplan at the ACH. Their results showed improved scores when the children, aged eight to 15, were tested for withdrawn behaviour, anxious/depressed behaviour, social problems, thought problems, attention, delinquent behavior and aggression.

“The results demonstrated statistically significant improvements in mood and anxiety in the nine children who completed the trial,” said the researchers. “Seven of the eight CBCL (Child Behaviour Checklist) scales revealed statistically significant improvements.”

Their report notes while two children experienced nausea, one of who had the flu, none discontinued because of adverse effects. Two who were taking psychiatric medication experienced moderate agitation and excitability.

This is the third such published study on Empowerplus for Dr. Kaplan who reported similar findings two years ago. “Most would agree that good nutrition is fundamental for good physical health,” the study says. “In contrast, the role of nutrition in maintaining good mental health is still a matter of considerable debate in spite of the fact that the importance of micronutrients (i.e., vitamins and minerals) for normal brain function is well established by decades of scientific research.”

The children involved – 11 began the trial, but two dropped out – had all displayed unstable mood and behavioral problems such as lengthy tantrums and explosive rage. They were clinically diagnosed with an anxiety, mood, or behavioral disorders by their referring clinicians and were on stable psychiatric medication regimens. All were physically healthy children whose families were knowledgeable about standard pharmacological treatment; nine had already tried several such medications.

The researchers note their results relied heavily on the observations of parents who “had specifically chosen an experimental nutritional supplement rather than traditional psychiatric medications.” “In the current health environment, there could be a large expectancy effect associated with the use of any natural health product,” the study says. “On the other hand, most of these children had been through multiple treatment programs, including medications, and expectancy effects in those situations did not appear to reach the magnitude of the treatment effect documented in this study.”

If there is a note of warning sounded in the study, it concerns adverse effects caused by the interaction of the nutrients with psychiatric medication. “We have noted that many adult and child patients who have taken this nutrient supplement in combination with psychiatric medications have experienced what appear to be significant problems with interactions,” report the researchers. The manufacturer of Empowerplus recommends decreasing psychiatric medication when using its product. “Despite significant concerns about safety and clinical stability, this has appeared to us to be a reasonable approach,” say the researchers. “The nature of the interaction is difficult to specify, but it appears that the supplement amplifies the effect of psychiatric medications.”

In fact, the three children taking medication who completed the trial were able to decrease their dosage and still benefit from the Empowerplus. “Based on these data and previous research, it appears that nutritional supplementation may exert a stabilizing effect on mood, temper, and anxiety in a manner that is relatively independent of diagnostic category,” confirms the study. “Even though the effect is nonspecific, it appears to be strong and clinically useful.”